Inflammatory Bowel DiseasesNCT06995170
Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression
An observational study of Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Xijing Hospital at 1 site in China.
Trial summary
Inflammatory Bowel Disease (IBD), encompassing Ulcerative Colitis (UC) and Crohn's Disease (CD), significantly impairs patients' quality of life. Current monitoring of disease activity primarily relies on endoscopy combined with histological examination, which is associated with high costs, invasiveness, poor patient… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD patients aged 18-65 years were recruited from The First Affiliated Hospital of the Air Forth Medical University.
Who may be able to join
- Age between 18 and 65 years;
- Diagnosed with inflammatory (IBD) according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an) and the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou);
- Complete medical records available and written informed consent obtained from the participant.
Who cannot join
- Presence of other metabolic disorders;
- History of malignant tumors, severe organ dysfunction, or other severe systemic diseases affecting major organs, or hematological disorders;
- Diagnosis of influenza, bacterial dysentery, or other infectious diseases within the past 2 weeks;
- Presence of other diseases that may interfere with polyamine metabolism;
- Use of antibiotics or probiotics within 8 weeks prior to the start of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Hao Zhang, +86 13677056116, 514602793@qq.com
About this study
Inflammatory Bowel Disease (IBD), encompassing Ulcerative Colitis (UC) and Crohn's Disease (CD), significantly impairs patients' quality of life. Current monitoring of disease activity primarily relies on endoscopy combined with histological examination, which is associated with high costs, invasiveness, poor patient tolerance, and risks of complications. Additionally, disease activity indices and laboratory-based IBD staging metrics demonstrate limited utility and accuracy in clinical practice. This study aims to investigate the correlation between polyamine levels and their key enzymes in the polyamine metabolism pathway with IBD activity, thereby establishing a predictive model for IBD progression through polyamine and metabolite measurements; to estimate the efficacy of biologics via polyamine detection, providing a scientific basis for therapeutic selection; and to screen gut microbiota associated with polyamine metabolic alterations, offering evidence-based guidance for probiotic selection in IBD patients.
Read the detailed description
According to the inclusion and exclusion criteria, 91 patients with IBD diagnosed in the Department of Gastroenterology, the First Affiliated Hospital of Air Force Medical University from November 2024 to September 2025 were included, and the subjects were divided into remission group and active group according to the corresponding IBD scale scores; 46 healthy controls were generally included according to the number of patients; In addition, 47 patients in the first biologic treatment group were included according to the inclusion and exclusion criteria. The FFQ scale was used to calculate and evaluate the intake of polyamines in the enrolled patients, high performance liquid chromatography and mass spectrometry were used to measure the levels of polyamines in serum and fecal samples of patients, and immunohistochemical semi quantitative analysis of colon pathological sections was used to analyze the levels of key enzymes of polyamine metabolism.
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD group | IBD patients aged 18-65 years were categorized into remission and active-phase groups according to corresponding clinical scoring scales. IBD patients will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025. | |
| Healthy subjects | Age-, gender-, and education level-matched healthy controls will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025. | |
| First-line biologics group | 18-65-year-old Inflammatory Bowel Disease (IBD) patients planned for the first administration of Infliximab will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
For patients with recent colonoscopy results: UC patients are assessed for disease activity using the modified Mayo score, while CD patients are evaluated using the SECA score.
For patients without recent colonoscopy results: UC patients are assessed for disease activity using the Modified Truelove and Witts Grading System, and CD patients are evaluated using the SCAI for disease activity assessment.
The modified Mayo score:Clinical remission is defined as a total score of ≤2 points and no single sub-item score >1. Mild activity is defined as 3-5 points, moderate activity as 6-10 points, and severe activity as 11-12 points.
SECA:0 ~ 2 Indicates endoscopic remission,3 ~ 6 suggests mild disease activity,7 ~ 15 indicates moderate disease activity,≥16 reflects severe disease activity.
SCAI: Total score ≤4: Indicates endoscopic remission. 5-7: Suggests mild disease activity. 8-16: Reflects moderate disease activity. >16: Signifies severe disease activity.
Measured: at baseline
The level of polyamine
The levels of putrescine, spermidine, N1-acetylspermidine, ornithine, citrulline, N1-acetylspermidine, N1-acetylspermine, N8-acetylspermidine, N-acetylornithine, N1,N12-diacetylspermine, and N-acetylputrescine in serum, feces, and urine are measured using mass spectrometry. Results will be reported in nmol/L, with levels potentially reflecting disease activity.
Measured: at baseline and 8weeks
Food Frequency Questionnaire
Including 9 food groups and 59 food items. The patient's total monthly polyamine intake is calculated by multiplying the total monthly consumption of each food item by its corresponding polyamine content.Total polyamine intake (mg/month) = Σ (Food consumption [g/month] × Polyamine content [mg/g])
Measured: at baseline
Gastrointestinal Microbiome
Fecal samples of some participants will be collected and prepared. DNA will be extracted from the stool samples, and the V3-V4 hypervariable region of bacterial 16S rRNA gene was sequenced.
Measured: at baseline
Secondary outcomes (1)
polyamine metabolic enzymes
Intestinal mucosal sections were stained with immunohistochemistry to quantify the content and distribution of the key polyamine metabolic enzyme Ornithine Decarboxylase (ODC).
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaichun Wu, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995170
- Sponsor's protocol ID
- KY20242438
- Status last verified
- Mar 2025
- First submitted
- 14 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression
- ClinicalTrials.gov ID
- NCT06995170
- Acronym / sponsor ID
- KY20242438
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammatory Bowel Disease (IBD), encompassing Ulcerative Colitis (UC) and Crohn's Disease (CD), significantly impairs patients' quality of life. Current monitoring of disease activity primarily relies on endoscopy combined with histological examination, which is associated with high costs, invasiveness, poor patient tolerance, and risks of complications. Additionally, disease activity indices and laboratory-based IBD staging metrics demonstrate limited utility and accuracy in clinical practice. This study aims to investigate the correlation between polyamine levels and their key enzymes in the polyamine metabolism pathway with IBD activity, thereby establishing a predictive model for IBD progression through polyamine and metabolite measurements; to estimate the efficacy of biologics via polyamine detection, providing a scientific basis for therapeutic selection; and to screen gut microbiota associated with polyamine metabolic alterations, offering evidence-based guidance for probiotic selection in IBD patients.
Detailed description
According to the inclusion and exclusion criteria, 91 patients with IBD diagnosed in the Department of Gastroenterology, the First Affiliated Hospital of Air Force Medical University from November 2024 to September 2025 were included, and the subjects were divided into remission group and active group according to the corresponding IBD scale scores; 46 healthy controls were generally included according to the number of patients; In addition, 47 patients in the first biologic treatment group were included according to the inclusion and exclusion criteria. The FFQ scale was used to calculate and evaluate the intake of polyamines in the enrolled patients, high performance liquid chromatography and mass spectrometry were used to measure the levels of polyamines in serum and fecal samples of patients, and immunohistochemical semi quantitative analysis of colon pathological sections was used to analyze the levels of key enzymes of polyamine metabolism.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD group | – | –IBD patients aged 18-65 years were categorized into remission and active-phase groups according to corresponding clinical scoring scales. IBD patients will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025. |
| Healthy subjects | – | –Age-, gender-, and education level-matched healthy controls will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025. |
| First-line biologics group | – | –18-65-year-old Inflammatory Bowel Disease (IBD) patients planned for the first administration of Infliximab will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients aged 18-65 years were recruited from The First Affiliated Hospital of the Air Forth Medical University.
Key inclusion criteria (3 listed)
- Age between 18 and 65 years;
- Diagnosed with inflammatory (IBD) according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an) and the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou);
- Complete medical records available and written informed consent obtained from the participant.
Key exclusion criteria (5 listed)
- Presence of other metabolic disorders;
- History of malignant tumors, severe organ dysfunction, or other severe systemic diseases affecting major organs, or hematological disorders;
- Diagnosis of influenza, bacterial dysentery, or other infectious diseases within the past 2 weeks;
- Presence of other diseases that may interfere with polyamine metabolism;
- Use of antibiotics or probiotics within 8 weeks prior to the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease activity
Time frame: at baseline
For patients with recent colonoscopy results: UC patients are assessed for disease activity using the modified Mayo score, while CD patients are evaluated using the SECA score. For patients without recent colonoscopy results: UC patients are assessed for disease activity using the Modified Truelove and Witts Grading System, and CD patients are evaluated using the SCAI for disease activity assessment. The modified Mayo score:Clinical remission is defined as a total score of ≤2 points and no single sub-item score >1. Mild activity is defined as 3-5 points, moderate activity as 6-10 points, and severe activity as 11-12 points. SECA:0 ~ 2 Indicates endoscopic remission,3 ~ 6 suggests mild disease activity,7 ~ 15 indicates moderate disease activity,≥16 reflects severe disease activity. SCAI: Total score ≤4: Indicates endoscopic remission. 5-7: Suggests mild disease activity. 8-16: Reflects moderate disease activity. >16: Signifies severe disease activity.
The level of polyamine
Time frame: at baseline and 8weeks
The levels of putrescine, spermidine, N1-acetylspermidine, ornithine, citrulline, N1-acetylspermidine, N1-acetylspermine, N8-acetylspermidine, N-acetylornithine, N1,N12-diacetylspermine, and N-acetylputrescine in serum, feces, and urine are measured using mass spectrometry. Results will be reported in nmol/L, with levels potentially reflecting disease activity.
Food Frequency Questionnaire
Time frame: at baseline
Including 9 food groups and 59 food items. The patient's total monthly polyamine intake is calculated by multiplying the total monthly consumption of each food item by its corresponding polyamine content.Total polyamine intake (mg/month) = Σ (Food consumption [g/month] × Polyamine content [mg/g])
Gastrointestinal Microbiome
Time frame: at baseline
Fecal samples of some participants will be collected and prepared. DNA will be extracted from the stool samples, and the V3-V4 hypervariable region of bacterial 16S rRNA gene was sequenced.
1 secondary outcome
polyamine metabolic enzymes
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaichun Wu principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhang (+8613677056116, 514602793@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity (time frame: at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.